Standards are vitally important in the Chemical and Pharmaceutical Industry to ensure product quality, compliance, and Process Safety.
Manufacturers in this sector must take into account the proper application of company regulations and the respect of good manufacturing practices throughout the production chain. They must be able to evaluate and manage industrial risks, while having good cost control.
CMMS software that is adapted to this sector can therefore become an essential tool to facilitate the management of these industries and meet the requirements of standards :
- Information Traceability
- Process Safety Management
- Inventory Management (batch numbers etc.)
- Electronic signatures
- Restricted accesses (encryption of passwords)
- and so forth
Title 21 CFR (Code of Federal Regulations), Part 11 Standard :
The CFR Title 21, Part 11 Standard, issued by the FDA (Food & Drug Administration) in 1997, focuses on the traceability of information and the signing of electrical records.
It states a number of requirements essentially related to authenticity, integrity and confidentiality of electronic records and signatures. This requires the use of procedures and controls on closed and secured electronic filing systems. Access must be limited to accredited persons, checks must be put in place for each step etc.
Risks for applications that do not comply with FDA 21 CFR Part. 11 standards :
Any (computer or paper) application can potentially be controlled by an FDA auditor. Failure to comply with certain standard referential points may result in fines, or a complete shutdown of production in case of non-compliance of products.
In comparison with the cost of a production shutdown, investing in an IT solution quickly pays off.
CMMS software makes it possible to systematically record each piece of data and to validate using electronic signing. Data can be stored as recommended by the FDA and remains available. It is possible at any time to retrace task logs performed by a user in the software.
One MAINTI4®’s specificity is being able to adapt to each business according to its unique needs.
For the Chemical and Pharmaceutical Industry, governed by precise and demanding standards, MAINTI4® offers optimal management in compliance with standards.
Using the right CMMS tool makes it easier to meet the requirements of Title 21 CFR Part 11 standards.
What initially seemed to be a constraint, becomes a source of improvement for your Service.